MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA FEMORAL HEAD 40MM OD, -3.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 170-40-93

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

Pending investigation.Concomitant medical products: 6774617, 01-010-16-4195 - mono rev stem std 16x195, 2022-09.

Event Description

As reported, the female, morbidly obese patient had a revision right hip surgery for re-implantation, post-infection, on (b)(6) 2022.The patient was implanted with a competitor's acetabular component and an exactech hip monobloc stem, along with a ceramic femoral head.The patient presented back with a re-infection of the right hip post-revision surgery.The patient was scheduled for a right hip i&d and explant of hip implants on (b)(6) 2023.All implants, including the exactech revision hip stem and head, were removed and an antibiotic spacer hip implant was implanted into the patient.The patient will be monitored for infection follow-up.There is no reported breakage of devices and a 30-45 minute surgical delay/prolongation as the patient underwent extensive irrigation and debridement for infection.The patient required prolonged hospitalization as a direct result of this issue.No other patient information/medical history reported.

Manufacturer Narrative

H3: the cause of the patient¿s infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.

• Brand Name: BIOLOX DELTA FEMORAL HEAD 40MM OD, -3.5MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16492629
• MDR Text Key: 310783547
• Report Number: 1038671-2023-00376
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862155535
• UDI-Public: 10885862155535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 170-40-93
• Device Catalogue Number: 170-40-93
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/20/2023
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Female